Dr Reddy's Is Knocked Back On US NuvaRing And Copaxone Rivals
Dr Reddy’s has received a further CRL from the US Food and Drug Administration over its application for a generic rival to Merck Sharp & Dohme’s NuvaRing contraceptive, along with a CRL for its version of Teva’s Copaxone.
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Following a trio of complete response letters received since late 2018, Mayne Pharma and partner Mithra Pharmaceuticals have finally obtained US FDA approval for a generic version of Organon’s NuvaRing vaginal hormonal contraceptive ring.
Australia’s Mayne Pharma has announced another complete response letter for its proposed generic version of Organon’s NuvaRing (etonogestrel/ethinylestradiol) contraceptive device, marking a trio of setbacks for the ANDA product.
Recent Canadian, European and US endorsements of Mithra’s estetrol-based Estelle novel oral contraceptive mark a “turning point” for the Belgian firm, which has also seen success with its Myring generic rival to NuvaRing for which it expects to see further launches this year.